Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-27 @ 2:32 PM
Study NCT ID:
NCT00800657
Status:
UNKNOWN
Last Update Posted:
2011-06-23
First Post:
2008-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stem Cells and Resynchronization Cardiac
Sponsor:
Instituto de Molestias Cardiovasculares
Organization:
Study Overview
Official Title:
Stem-Cells and Heart Failure in Several Ethiologies. Alternative Indication With Cardiac Resynchronization
Status:
UNKNOWN
Status Verified Date:
2011-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RCT and SCT
Brief Summary:
Same patients with dilated myocardiopathies with large areas of fibrosis has not been as successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant with Cardiac Resynchronization Therapy in these patients.
Detailed Description:
About 120cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution the mononuclear cells are injected into the cardiac muscles with fibroses area through 20 shots.This procedure is indicated for patients with cardiac ischemia and left ventricular dysfunction(desynchrony), on whom all the others known therapies have failed.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HFRCTC1 | None | None | View |